Effects of pregabalin, sulfenacin and the combination of these two drugs on symptoms associated with ureteral stent placement

Comparative study of the effect of perbabalin, sulfenacin and combination of these two drugs on the symptoms associated with Stent Double-J (USRS) insertion in ureter followed by ureteroscopy and lithotripsy transurethral in patients with ureteral stones

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090427001853N16

Enrollment

256

Registered

2018-02-16

Start date

2017-11-22

Completion date

Unknown

Last updated

2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary tract symptoms due to double-J stent insertion. Symptoms and signs involving the urinary system

Interventions

Intervention 1: Solifenacin 5mg,made in Iran, one daily for 4 weeks and antibiotic prophylaxis consists of pre-operative injections of cefazolin with amikacin, and postoperative oral ciprofloxacin 500

Eligibility

Sex/Gender

All

Age

18 Years to 139 Years

Inclusion criteria

Inclusion criteria: Participant's signature on the consent form At least 18 years of age Patients with single and unilateral ureteric stones requiring unilateral ureteral dual-gage (DJ) stenting and transurethral lithotripsy (TUL) for at least 4 weeks after uteroscopy and lithotripsy Negative urine culture before TUL and ureteral stent placement

Exclusion criteria

Exclusion criteria: Patients with a history of infravesical obstruction Patients taking chronic medications such as alpha-blocker or analgesic Patients with a history of neurogenic or overactive bladder Recurrent urinary tract infections or chronic pelvic pain Patients with renal function impairment (GFR <60) Patients with bilateral obstructive or bilateral ureteral stone Patients who undergo ureteroscopy and have a stent Patients with pregabalin contraindications (such as hypersensitivity, pregnancy, lactation, renal or hepatic dysfunction) Patients who have other urological surgeries at the time of urological surgeries

Design outcomes

Primary

Measure	Time frame
Ureteral stent symptoms. Timepoint: Before intervention, 2 and 4 weeks after intervention. Method of measurement: By relevant questions in the USSQ Standard Questionnaire.;The number of days with the episode of severe pain. Timepoint: 2 and 4 weeks after intervention. Method of measurement: Ask the patient and record in the questionnaire.;Total days of taking painkiller. Timepoint: The first week after the intervention. Method of measurement: Ask the patient and record in the questionnaire.	—

Measure

Time frame

Ureteral stent symptoms. Timepoint: Before intervention, 2 and 4 weeks after intervention. Method of measurement: By relevant questions in the USSQ Standard Questionnaire.;The number of days with the episode of severe pain. Timepoint: 2 and 4 weeks after intervention. Method of measurement: Ask the patient and record in the questionnaire.;Total days of taking painkiller. Timepoint: The first week after the intervention. Method of measurement: Ask the patient and record in the questionnaire.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammadreza Beigzadeh

Urology Research Center, Guilan University of Medical Sciences

urc1384@yahoo.com+98 13 3352 5259

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026